BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2120020 · Received June 8, 2011

    Report

    Report Number
    3007566237-2011-04134
    Event Type
    Injury
    Date Received
    June 8, 2011
    Date of Event
    November 6, 2009
    Report Date
    July 13, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS ARTICLE CAN BE ACCESSED ONLINE AT HTTP://THEJNS.ORG/DOI/PDF/10.3171/2009.10.JNS09917.

    Description of Event or Problem · 1

    LITERATURE: UMEMURA A, OKA Y, OHKITA K, YAMAWAKI T, YAMADA K. EFFECT OF SUBTHALAMIC DEEP BRAIN STIMULATION ON POSTURAL ABNORMALITY IN PARKINSON DISEASE. J NEUROSURG. JUN 2010;112(6):1283-1288. SUMMARY: THIS ARTICLE DISCUSSED THE EFFECTS OF SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION (STN-DBS) ON POSTURAL ABNORMALITIES IN 18 PTS WITH PARKINSON'S DISEASE. THE PTS RECEIVED BILATERAL IMPLANTATION FOR MOTOR COMPLICATIONS FOR LEVODOPA BETWEEN (B)(6) 2003 AND (B)(6) 2007. EIGHT PTS HAD CAMPTOCORMIA (BENT SPINE) AND 10 PTS HAD PISA-SYNDROME (LATERAL FLEXION). THE AUTHORS FOUND THAT MODERATE RATHER THAN SEVERAL POSTURAL ABNORMALITY TENDED TO IMPROVE IN THE EARLY STAGE AFTER STN-DBS SURGERY. REPORTABLE EVENT: ONE (B)(6) FEMALE PT WITH PISA-SYNDROME EXPERIENCED SEVERE SKIN EROSION AT THE SITE OF THE INTERNAL PULSE GENERATOR AND UNDERWENT SURGICAL REPAIR. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFO FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. AT THIS TIME NO ADDITIONAL INFO WAS AVAILABLE, ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC NEUROMODULATION 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention IMPLANTED:| EXPLANTED:| EXTENSION: MODEL UNK, LOT# UNK| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL UNK, LOT# UNK| IMPLANTED:| LEAD: MODEL 3389, LOT# UNK| IMPLANTED:| LEAD: MODEL 3389, LOT# UNK| EXPLANTED: